NDC 43857-0145 Allergen II

Kali Gluconicum, Adrenalinum, Hepar, Sheep Sorrel, Yellow Dock, Kentucky Blue Grass, Orchard Grass, Red Top Grass, Timothy Grass, Goldenrod, Red Clover, False Ragweed, Short Ragweed, Tall Ragweed, Western Ragweed, Ash, Beech, Red Birch, Box Elder, Cottonwood, Elm, Hickory, Red Oak, Sycamore, Black Walnut, Black Willow, Arsenicum Album, Phosphorus, Pulsatilla, Sulphur, Histaminum Hydrochloricum

NDC Product Code 43857-0145

NDC Code: 43857-0145

Proprietary Name: Allergen II What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Kali Gluconicum, Adrenalinum, Hepar, Sheep Sorrel, Yellow Dock, Kentucky Blue Grass, Orchard Grass, Red Top Grass, Timothy Grass, Goldenrod, Red Clover, False Ragweed, Short Ragweed, Tall Ragweed, Western Ragweed, Ash, Beech, Red Birch, Box Elder, Cottonwood, Elm, Hickory, Red Oak, Sycamore, Black Walnut, Black Willow, Arsenicum Album, Phosphorus, Pulsatilla, Sulphur, Histaminum Hydrochloricum What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.
    • 43857-0145 - Allergen

NDC 43857-0145-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Allergen II with NDC 43857-0145 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Allergen II is kali gluconicum, adrenalinum, hepar, sheep sorrel, yellow dock, kentucky blue grass, orchard grass, red top grass, timothy grass, goldenrod, red clover, false ragweed, short ragweed, tall ragweed, western ragweed, ash, beech, red birch, box elder, cottonwood, elm, hickory, red oak, sycamore, black walnut, black willow, arsenicum album, phosphorus, pulsatilla, sulphur, histaminum hydrochloricum. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Allergen II Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • POTASSIUM GLUCONATE 6 [hp_X]/mL
  • EPINEPHRINE 8 [hp_X]/mL
  • BEEF LIVER 8 [hp_X]/mL
  • RUMEX ACETOSELLA POLLEN 9 [hp_X]/mL
  • RUMEX CRISPUS TOP 9 [hp_X]/mL
  • POA PRATENSIS TOP 9 [hp_X]/mL
  • DACTYLIS GLOMERATA TOP 9 [hp_X]/mL
  • AGROSTIS GIGANTEA POLLEN 9 [hp_X]/mL
  • PHLEUM PRATENSE TOP 9 [hp_X]/mL
  • SOLIDAGO VIRGAUREA FLOWERING TOP 9 [hp_X]/mL
  • TRIFOLIUM PRATENSE FLOWER 9 [hp_X]/mL
  • ALFALFA 9 [hp_X]/mL
  • AMBROSIA ACANTHICARPA POLLEN 9 [hp_X]/mL
  • AMBROSIA ARTEMISIIFOLIA 9 [hp_X]/mL
  • AMBROSIA TRIFIDA POLLEN 9 [hp_X]/mL
  • AMBROSIA PSILOSTACHYA POLLEN 9 [hp_X]/mL
  • FRAXINUS AMERICANA POLLEN 9 [hp_X]/mL
  • FAGUS GRANDIFOLIA POLLEN 9 [hp_X]/mL
  • BETULA OCCIDENTALIS POLLEN 9 [hp_X]/mL
  • ACER NEGUNDO POLLEN 9 [hp_X]/mL
  • POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN 9 [hp_X]/mL
  • ULMUS AMERICANA POLLEN 9 [hp_X]/mL
  • CARYA OVATA POLLEN 9 [hp_X]/mL
  • QUERCUS RUBRA POLLEN 9 [hp_X]/mL
  • PLATANUS OCCIDENTALIS POLLEN 9 [hp_X]/mL
  • JUGLANS NIGRA POLLEN 9 [hp_X]/mL
  • SALIX NIGRA POLLEN 9 [hp_X]/mL
  • ARSENIC TRIOXIDE 12 [hp_X]/mL
  • PHOSPHORUS 12 [hp_X]/mL
  • PULSATILLA VULGARIS 12 [hp_X]/mL
  • SULFUR 12 [hp_X]/mL
  • HISTAMINE DIHYDROCHLORIDE 30 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bioactive Nutritional, Inc.
Labeler Code: 43857
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-22-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Allergen II Product Label Images

Allergen II Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients:

Kali Gluconicum 6X, Adrenalinum 8X, Hepar (Bovinum) 8X, Sheep Sorrel 9X, 12X, 30X, Yellow Dock 9X, 12X, 30X, Kentucky Blue Grass 9X, 12X, 30X, Orchard Grass 9X, 12X, 30X, Red Top Grass 9X, 12X, 30X, Timothy Grass 9X, 12X, 30X, Solidago Virgaurea 9X, 12X, 30X, Trifolium Pratense 9X, 12X, 30X, Alfalfa 9X, 12X, 30X, False Ragweed 9X, 12X, 30X, Short Ragweed 9X, 12X, 30X, Tall Ragweed 9X, 12X, 30X, Western Ragweed 9X, 12X, 30X, Ash 9X, 12X, 30X, Beech 9X, 12X, 30X, Red Birch 9X, 12X, 30X, Box Elder 9X, 12X, 30X, Cottonwood 9X, 12X, 30X, Elm 9X, 12X, 30X, Hickory 9X, 12X, 30X, Red Oak 9X, 12X, 30X, Sycamore 9X, 12X, 30X, Black Walnut 9X, 12X, 30X, Black Willow 9X, 12X, 30X, Arsenicum Album 12X, Phosphorus 12X, Pulsatilla 12X, Sulphur 12X, Histaminum Hydrochloricum 30X.

Indications:

For temporary relief of sinus congestion, symptoms due to hay fever and allergic rhinitis.

For temporary relief of sinus congestion, symptoms due to hay fever and allergic rhinitis.

Warnings:

If pregnant or breast-feeding, ask a health care professional before use.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.Do not use if tamper evident seal is broken or missing.Store in cool, dry place.

Directions:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized water, 25% Ethanol.

Keep Out Of Reach Of Children:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Questions:

Distributed by:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935bioactivenutritional.com*For a complete list of Pollen Allersodes contact BioActive Nutritional, Inc.

Package Label Display:

BIOActive NutritionalALLERGEN IIHOMEOPATHIC1FL OZ (30 ml)

* Please review the disclaimer below.

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